Guidance Documents – Legislation and guidelines – Veterinary drugs

In this Section:

Several guidance documents have been developed to help our stakeholders familiarize themselves with the regulatory requirements of the Food and Drugs Regulations that pertain to veterinary drug submissions.

In addition, Canada has adopted a number of VICH Guidelines that are available in the topics area to the left of your screen.

• Guidance for Industry: Preparation of Veterinary New Drug Submissions and Abbreviated New Drug Submissions (New and Generic Drugs) - Quality Requirements [2025-03-14]
• Guidance for Industry: Preparation of Veterinary Abbreviated New Drug Submissions (Generic Drugs) - Clinical and Human Safety Requirements [2025-03-14]
• About veterinary drug submission guidance documents [2025-03-14]
• List of needed veterinary drugs [2025-02-07]
• Regulatory cooperation: Canadian guidance on veterinary drug simultaneous reviews with the United States [2025-01-17]
• Classifying pheromone-based products for companion animals: Notice to stakeholders [2023-11-03]
• Post-Notice of Compliance (NOC) Changes: Guidance for quality of veterinary drugs [2023-08-28]
• Veterinary drugs master file updates and fees consultation: Notice [2023-06-02]
• Guidance document: Fees for reviewing applications for dealer’s licences for controlled drugs and substances (veterinary use only) [2023-04-17]
• Veterinary drug experimental studies [2022-12-13]
• Preparation of veterinary Drug Identification Number submissions [2022-11-08]
• Guidance on veterinary drug labelling [2022-09-13]
• Notice: Revised guidance documents on Post-Notice of Compliance changes for veterinary drugs [2022-07-28]
• Post-Notice of Compliance changes: Framework document for veterinary drugs [2022-07-28]
• Post-Notice of Compliance changes: Guidance for safety and efficacy of veterinary drugs [2022-07-28]
• Classification of products for use in animals [2022-06-27]
• Veterinary drugs - Management of regulatory submissions guidance
  [in effect as of 2021-11-12]
• Notice: Submission Filing Recommendations for Veterinary Drugs - Good Manufacturing Practices (GMP)/Drug Establishment Licences (DEL) [2020-02-16]
• Guidance on Veterinary Drug Joint Reviews [2020-08-13]
• Guidance on procedures and administrative requirements for master files [2024-01-02]
• Antiseptic Teat Solutions Monograph [2018-06-08]
• Guidance Document: Patented Medicines (Notice of Compliance) Regulations [2018-06-08]
• Notice - Prescription Drug List (PDL): Multiple Additions [2017-10-19]
• Updates to the Prescription Drug List [2017-10-19]
• Notice - Publication of the Health Canada Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions [2017-08-21]
• Notice: Publication of Update to the Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations [2017-05-17]
• English-French Lexicon for Standard Labelling Statement [2017-05-01]
• Guidance document on classification of veterinary drugs and livestock feeds [2017-04-12]
• Updated - Guidance Document: Preparation of Regulatory Activities in the "Non-eCTD Electronic-Only" Format [2017-02-02]
• Prescription Drug List [2017-04-21]
• Notice - Prescription Drug List (PDL): Multiple Additions [2015-10-16]
• Prescription Drug List [2015-08-12]
• Amendments to the Food and Drugs Act Guide to New Authorities [2015-07-31]
• Consultation on the Amendments to the Food and Drugs Act: Guide to New Authorities - What We Heard [2015-07-31]
• Common Electronic Submissions Gateway [2014-01-31]
• Guidance Document: Determining Prescription Status for Human and Veterinary Drugs [2013-06-21]
• Questions and Answers - Prescription Drug List [2013-12-20]
• Consultation on the new Prescription Drug List [2012-12-24]
• Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations
• French-English Lexicon for Standard Labelling Statements
• Guidance Document: Fees for the Review of Veterinary Drug Submissions and Applications (formerly Guidance Document on Cost Recovery - Veterinary Drug Submission Evaluation Fees)
• Guidance for Industry - Preparation of Veterinary New Drug submissions
• Guidance for Industry - Preparation of Veterinary Abbreviated New Drug Submissions - Generic Drugs
• Guidelines for Evaluation of Safety and Efficacy of Teat Dip Formulations
• Notice - Post-Notice of Compliance (NOC) Changes Guidance Documents
• Veterinary New Drug List
• Annex 4 to the Current Edition of the Good Manufacturing Practices Guidelines - Veterinary Drugs (GUI-0012)
• Notice: Guidance Document Updates to Reflect New Fees and Policies for April 1, 2020